Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: Hemodynamic Instability

Treatments: Drug: Propofol; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05644483

2021-1514

Details and patient eligibility

About

Most of the major spinal surgeries are performed in the supine position, which causes a decrease in stroke volume and cardiac index, which leads to the occurrence of hypotension during surgery. Postoperative hypotension causes an imbalance in the supply and demand of oxygen, leading to postoperative myocardial infarction or acute renal damage, and may increase mortality one year after surgery. Propofol, which is most commonly used for total intravenous anesthesia, can further increase the incidence of hypotension during surgery. Therefore, there is a continuing demand for an anesthetic agent that is more hemodynamically stable. Remimazolam, an ultra-short acting benzodiazepine that has a similar structure to midazolam, but whose activity is terminated by esterase hydrolysis, is expected to have less hemodynamic effects than propofol. Therefore, the purpose of this study is to investigate the effect of general anesthesia using remimazolam and general anesthesia using propofol on hemodynamic safety during surgery in patients undergoing major spinal surgery in the supine position.

Enrollment: 94 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA physical status: 1-3
• age: 19-80 years
• patients who are scheduled to undergo a major spine surgery in the prone position

Exclusion criteria

• patients who refuse to participate
• body mass index: <15kg/m2 or >35kg/m2
• patients with uncontrolled hypertension, hyperthyroidism, severe cardiac disease
• patients who are contraindicated to the use of remimazolam including severe hepatic disease, acute glaucoma, shock, acute alcohol intoxication
• allergic to propofol and midazolam
• patients who are judged unsuitable to participate in the study for other reasons by medical staffs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

94 participants in 2 patient groups

remimazolam group

Experimental group

Description:

patients who receive remimazolam-remifentanil based total intravenous anesthesia

Treatment:

Drug: Remimazolam

propofol group

Active Comparator group

Description:

patients who receive propofol-remifentanil based total intravenous anesthesia

Treatment:

Drug: Propofol